Safety and Efficacy of Catheter Ablation of Idiopathic Ventricular Arrhythmias Arising From Cardiac Outflow Tracts
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03258112|
Recruitment Status : Not yet recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Ventricular arrhythmias arising from cardiac outflow tract affect quality of life and can cause decrease in left ventricular ejection fraction.
Drugs used for treating those arrhytmias may be ineffective or may have side effects.
Radiofrequency catheter ablation can be used safely for treatment of outflow tract arrhythmias.
There are different sites where those ventricular arrhythmias may originates, each site has different electrocardiographic characteristics, different procedural success rates and challenges in localization and ablation.
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Arrythmia||Procedure: Radiofrequency cardiac catheter ablation||Not Applicable|
The right and left ventricular outflow tracts (RVOT/LVOT) are the most common sites of origin for idiopathic ventricular tachycardia (VT) and premature ventricular contractions (PVCs) in patients without structural heart disease.1
Frequent PVCs was associated with PVC-induced cardiomyopathy, and radiofrequency (RF) catheter ablation of frequent PVCs was associated with improvement of left ventricular ejection fraction (LVEF).2
The most common underlying pathophysiological mechanism was identified to be triggered activity and RF catheter ablation treatment is highly effective with low complication rates.1,3 Drug therapy has limited effectiveness (in case β-blockers and calcium-channel blockers) or drug-related side effects ( in case of flecainide, propafenone and amiodarone).4
RF catheter ablation is recommended in cases of high PVC burden associated with decreased LV ejection fraction (LVEF) or in highly symptomatic patients despite optimal drug therapy.3
Although the RVOT is the most common site (about 70-80% of cases) for idiopathic VAs1,5, only few studies have reported on the prevalence and RF catheter ablation of ventricular arrhythmias (VAs) arising from the pulmonary artery (21-46% among the RVOT VAs)6 and even less prevalence is reported in VAs arising from the pulmonary sinus cusps (11%).7
Compared with VAs originating from the RVOT, ablation of LVOT-VAs is more complex and reported to be 12-45% of all idiopathic VAs.8-11 The success rate of ablation of LVOT-VA sites was previously reported to be lower (55-60%) without using antegrade/transseptal approaches.12,4 Rarely, it requires epicardial ablation via the GCV/AIV or subxiphoid puncture.13,14
There are some cases in which RF catheter ablation cannot successfully be performed from either LVOT or RVOT. In such cases the VAs may originate from the LV-summit which is the most common site of idiopathic epicardial VAs from the LVOT region.13
Although most idiopathic VAs originating from the cardiac OTs are suitable targets for endocardial RF catheter ablation, a small percentage of failures in these patients may be because of an inaccessible site of origin from epicardial or intramural septal locations.15The identification, mapping and RF catheter ablation of these idiopathic VAs may be challenging for the electrophysiologist and need special consideration.16
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Catheter Ablation of Idiopathic Ventricular Arrhythmias Arising From Cardiac Outflow Tracts|
|Estimated Study Start Date :||October 2017|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||April 2019|
all patients indicated for catheter ablation of RVOT or LVOT ventricular arrhythmia are included in one arm for electrophysiological diagnosis of the origin of arrhythmia then for radiofrequency catheter ablation
Procedure: Radiofrequency cardiac catheter ablation
procedure used for ablation of ventricular arrhythmia using catheters introduced to target sites percutaneously through venous or arterial systems using radiofrequency power
- procedural success [ Time Frame: 24 hours after the procedure ]success of the procedure in ablation of ventricular arrhythmia with termination of ventricular arrhythmia, absence of induction of arrhythmia and 24 hours electrocardiographic monitoring after the procedure documenting absence of ventricular arrhythmia
- Recurrence of ventricular arrhythmia after three months [ Time Frame: Three months ]Appearance of symptoms of palpitation and documentation of recurrence of same type of arrhythmia with prolonged electrocardiographic monitoring in case of symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258112
|Contact: Mohamed Abo Elhassan abdel-Radyfirstname.lastname@example.org|
|Principal Investigator:||Mohamed Abo Elhassan Abdel-Rady||Assiut University|